FDA Warns Sellers of Illegal Tianeptine Supplements

Megan Brooks

November 21, 2018

The US Food and Drug Administration (FDA) has sent warning letters to two companies illegally marketing dietary supplements containing the unapproved antidepressant tianeptine (Stablon, Serdia Pharmaceuticals), which the companies claim can relieve opioid addiction, pain, and anxiety.

The warning letters were sent to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product.

 

These products contain tianeptine, are marketed as dietary supplements, and make several "unproven and unlawful" claims, the FDA said, including the following:

  • "There has never been such a clear choice for pain and anxiety."

  • "Produces both stimulatory and opiate-like effects"

  • "Induces euphoria…"

  • "…pain-killer, euphoriant, speed-ball in a bottle, stress-reducing agent…"

Using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments, delay their path to recovery, and put them at greater risk of dying, FDA Commissioner Scott Gottlieb, MD, said in a statement.

The FDA has received reports of serious adverse events associated with the use of dietary supplements containing tianeptine, which is currently not approved in the United States for any use.

Tianeptine use can cause significant neurologic, cardiovascular, and gastrointestinal symptoms, with some effects mimicking opioid toxicity and withdrawal, the FDA said. Last summer, the US Centers for Disease Control and Prevention (CDC) reported an increase in calls to poison control centers regarding tianeptine exposure, suggesting a possible emerging public health risk. 

'Preying on Vulnerable Patients'

"We've seen growing instances where profiteers are pushing potentially dangerous compounds – often with unproven drug claims and crossing the line when it comes to what defines a dietary supplement," said Gottlieb.

"These potentially illegal activities put the entire dietary supplement industry at risk by confusing consumers, harming patients, and tainting good dietary supplement products by associating them with the activities of bad actors.

"In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder. They're also selling products with known safety issues. We won't stand by and allow this to happen. These warning letters are one part of our enforcement plan and we'll continue to take action to protect public health," he said.

The FDA has requested responses from Jack B Goods Outlet Store and MA Labs within 15 working days of receipt of the warning letter, which was dated November 7. Failure to correct violations may result in legal action without further notice, including, without limitation, seizure and injunction, the FDA said.

Healthcare professionals are encouraged to report any adverse events related to these products to MedWatch, the FDA's safety information and adverse event reporting program.

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